CLEOPATTRA

CLEOPATTRA: Effects of NNC6019-0001 versus placebo on cardiovascular outcomes in participants with transthyretin amyloid cardiomyopathy (ATTR-CM)

medical-cross
Amyloidosis
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All genders
person-wave 18+
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Overview
Principal Investigator: Ayan Patel, MD

This is an interventional, randomised, multinational, multicentre, two arm parallel-group, double-blind, cardiovascular (CV) outcomes trial (CVOT). The aim of this study is to evaluate the effect of NNC6019-0001 4800 mg versus placebo (randomised 1:1 and added to standard of care [SoC]) on CV death and morbidity in 1280 participants with variant or wild-type transthyretin (TTR) amyloid cardiomyopathy (ATTRv-CM or ATTRwt-CM, respectively).

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Gaurav Das / Abena Adwetewa-Badu (Abena.Adwetewa-Badu@tuftsmedicine.org)

Study details
Inclusion Criteria
  • Have an established diagnosis of ATTR-CM (ATTRwt or ATTRv), with cardiac amyloid infiltration, increased LV wall thickness, and HF.
  • NT-proBNP concentration ≥1000 pg/mL at screening.
  • Expected to be on stable CV medical therapy (defined as no greater than 50% dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomization visit.
Exclusion Criteria
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  • Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.
  • HF not primarily caused by ATTR-CM, for example, due to hypertension, valvular heart disease, or ischemic heart disease in the opinion of the investigator.
Study Requirements

Your participation in this research study will involve study visits every 4 weeks and will last at least 23 months and a total estimated duration of 52 months (approximately 4 years). Approximately a total of 531 mL (about 36 tablespoons) of blood will be collected for all required blood tests during the study. No more than 60 mL (about 12 teaspoons) of blood will be collected at any study visit. You will get an echocardiogram at screening, during randomization, at 6, 12, 24,36 and 48 months after randomization.